Melanoma is the deadliest skin cancer, with an estimated 97,610 new cases of melanoma in 2023, which accounts for 5% of all new cancer diagnoses, and the 7,990 deaths account for 1.3% of all cancer deaths.1 Due to heterogeneous response rates to the advanced therapeutics of targeted therapy and immunotherapy, including immune checkpoint inhibitors (ICIs), patient outcomes are uncertain.2 The US Food and Drug Administration (FDA) recently approved the extended use of adjuvant pembrolizumab for earlier-stage melanomas, IIB and IIC.3 In 2022, the FDA approved a combination ICI therapy, nivolumab plus relatlimab, as it has a similar toxicity profile to single-agent nivolumab and improved outcomes without a decrease in quality of life.4

Health-related quality-of-life (HRQoL) is an individual's mental and physical health perception based on variables of health risks and conditions, functional status, social support, and socioeconomic status.5 Assessment of HRQoL in chronic diseases such as cancer is best achieved using patient-reported outcome (PRO) instruments. PRO instruments assess the patient experience, which may include symptoms of illness and therapy impacts on an individual's HRQoL, including function, activity, and relationships, providing data beyond the survival benefit of treatment.

ICIs are widely believed to be well tolerated without negatively affecting HRQol.6,7 However, emerging evidence suggests that with the expanded use of ICI therapy in the community, patients experience adverse events and severe toxicities that negatively affect HRQoL.8, 9, 10, 11, 12, 13 This discrepancy suggests limitations in our current assessment of HRQoL and symptoms in patients receiving ICI therapy and the need for disease- and treatment-specific PRO measures for use in this population.

A handful of studies have delineated the symptom experience among people living with melanoma, including survivors and patients receiving specific ICI therapies (ie, pembrolizumab), but sparse data are available to understand the patient experience while undergoing ICI therapy.14, 15, 16, 17 While symptom presence and severity have been established in novel ICI clinical trials, qualitative descriptions of the symptom experience from the patient's perspective are lacking.18, 19, 20, 21, 22 Thus, the aim of this study was to explore the patient experience using descriptions of their words via interviews and evaluate and quantify their symptom burden and interference with the PRO instruments. To our knowledge, this is the first study using PRO instruments and participant interviews to understand the patients’ lived experience of undergoing ICI therapy for advanced melanoma, including nivolumab combined with relatlimab.